Nexalin Technology says FDA reaches consensus on design for HALO studies

Nexalin Technology announces that the U.S. Food and Drug Administration has provided feedback and reached consensus on the design for its planned clinical studies in anxiety and insomnia for its new Gen-3 HALO Clarity, a non-invasive, Deep Intracranial Frequency Stimulation headset device designed to address the global mental health epidemic. After the studies are completed and evaluated, Nexalin plans to submit a De Novo request application for the HALO to the FDA. The De Novo request provides a marketing pathway to classify new novel medical devices. The initial pilot and pivotal studies for anxiety and insomnia are expected to commence in the third quarter of 2024. Each of the pivotal studies will include 75 patients receiving active treatment and 75 patients receiving sham treatment and are intended to evaluate HALO’s ability to reduce symptoms of anxiety and insomnia, respectively. These two studies are intended to build on the positive results of prior published clinical studies evaluating Nexalin’s Gen-3 HALO utilizing the new advanced DIFS waveform.